Cleared Traditional

K853710 - THERACUSHION

K853710 is an FDA 510(k) clearance for THERACUSHION, manufactured by General Physiotherapy, Inc.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K853710 · General Physiotherapy, Inc. · Physical Medicine device
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Jan 1986
Decision
120d
Days
Class 1
Risk

K853710 is an FDA 510(k) clearance for the THERACUSHION. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by General Physiotherapy, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all General Physiotherapy, Inc. devices

FDA 510(k) Submission Details - K853710

510(k) Number K853710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1985
Decision Date January 03, 1986
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 28
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K853710.
BODY SOOTHER
K924518 · Conair Corp. · Oct 1993
BODY TRAINER
K924520 · Conair Corp. · Sep 1993
VIBRATOUCH II CORDLESS WAND MASSAGER
K912383 · Conair Corp. · Oct 1991
VACOMED 4
K842802 · Robert Bosch Corp. · Aug 1984
SENSORY ROLLER MASSAGER
K833090 · Maddak, Inc. · Oct 1983
MAGIC CUSHION MASSAGER
K810447 · Fred Sammons, Inc. · Mar 1981